Medicare to cover artificial hearts in clinical trials setting
Device Regulation Alert: Safety, Compliance and Reimbursement News, May 12, 2008
On May 1, CMS issued a final National Coverage Determination that provides Medicare coverage for artificial heart devices implanted as part of an FDA-approved study that meets certain criteria. The final determination follows a proposal issued in February that CMS reported was well-received by the public.
Although CMS does not believe artificial hearts meet reasonable and necessary requirements under Medicare law, it said enough evidence exists to show their potential. Therefore Medicare will support additional research concerning the device by covering its use in trials that meet specific criteria.
To be covered, the device must be used in a study that answers at least one of the following questions:
- Did unique circumstances (e.g. a facility’s expertise) or conditions (unusual combination of conditions in a patient) affect outcomes?
- What will be the average time to device failure once larger numbers of patients receive the device?
- Will study results reasonably predict the full range of outcomes likely to result from widespread use of the devices?
The study must also meet 14 specific criteria spelled out in the coverage determination. Additionally, to be deemed a qualifying study, the principal investigator must submit to CMS specific documentation about the study including:
- The study protocol
- A protocol summary
- Contact information
- Clinicaltrials.gov registration number
- A statement that the study answers one of the three questions above
- A statement the study protocol has FDA acceptance
- A statement the study meets the study standards required
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